BioPerspectives

GEN BioPerspectives is a content forum where life science thought leaders share scientific insights or talk in their own words about issues that may enhance your research. This content is produced solely by GEN's marketing partners. More on Bioperspectives here, or email us at bioperspectives@genengnews.com.

Sep 17, 2013

Personalized Medicine and Patent Eligibility

Companies seeking to protect their discoveries should understand the types of patented methods that courts are likely to consider enforceable.

Interest in personalized medicine continues to grow as scientists increasingly link gene sequences and other biomarkers to various diseases and disorders. Personalized medicine may benefit patients significantly by identifying particular individuals more likely to respond to a particular therapy. More accurate diagnoses based on analyses of gene sequences and other biomarkers should permit targeted treatments to achieve improved outcomes.

Gene sequences and other biomarkers are usually easy to access and analyze. But linking them to various diseases and disorders typically requires substantial time, effort, and expense. Companies desiring to protect their discoveries in this area—and the substantial investments they rest on—should understand the types of patented methods that courts will likely consider enforceable and the actors likely liable for infringement.

Divided Infringement

As background, joint or divided infringement addresses situations where no single actor performs every step in a method claim. Divided infringement occurs where (a) the claim specifies multiple steps and (b) two or more actors each perform at least one of the steps and they collectively perform all of the steps. Issues involving divided infringement typically arise when considering induced infringement of method claims.1

Last year, in Akamai v. Limelight the Court of Appeals for the Federal Circuit decided that induced infringement of method claims can occur in two situations: (1) where one entity performs one or more steps in a method claim and induces others to perform the remaining steps; and (2) where one entity performs no steps in a method claim but induces others to collectively perform all steps.2

The divided-infringement issue arises in many technological contexts, such as e-commerce (merchant and customer), cloud computing (providers and users), education (teacher and student), medical products (maker and user), and medical treatments (doctor and patient).

The Akamai decision gives claim drafters more flexibility to craft claims that encompass the actions of multiple entities. When preparing claims intended to encompass the actions of multiple entities, the drafter should understand the relationships among the various entities, what entities will likely perform what steps, and what entities will likely induce the performance of what steps.

Since claim drafters now have more flexibility in preparing claims covering multiple entities who collectively perform a method, they can prepare claims that will more likely survive challenges to patent eligibility without diminishing the ability to establish liability for inducement. That flexibility should help those working in, among other areas, personalized medicine and diagnostics-related technologies.

Claim Limits

But there are limits on claim breadth in these technologies. As an example, last year in Mayo v. Prometheus the Supreme Court ruled that method claims for optimizing the therapeutic efficacy of certain drugs did not recite patent-eligible subject matter because they effectively claimed laws of nature.3 Although the patent statute broadly identifies patent-eligible subject matter, the Supreme Court has ruled in various cases that laws of nature, physical or natural phenomena, and abstract ideas/mental processes are not eligible for patent protection.4

The claims at issue in Mayo specified (1) administering a thiopurine compound to a patient and (2) determining the level of a thiopurine metabolite in the patient.5 The claims then stated that a metabolite level less than concentration X indicated a need to increase the dosage and that a metabolite level greater than concentration Y indicated a need to decrease the dosage.6 But the claims did not require that a doctor adjust the dosage based on the metabolite level.7

The Supreme Court deemed the claims invalid for failing to recite patent-eligible subject matter because they did little more than inform doctors about the relevant laws of nature—the correlations between metabolite levels and the likelihood of harm or ineffectiveness.8

As another example, the Federal Circuit in Classen v. Biogen considered a similar patent eligibility issue involving method claims for reducing the risk of certain diseases, such as diabetes and asthma, when immunizing infants and children.9 The claims in two patents basically recited three steps: (1) screening immunization schedules by identifying different patient populations that were immunized according to different schedules; (2) comparing the effectiveness of the different immunization schedules in reducing the risk of disease and then identifying a lower-risk schedule; and (3) immunizing a patient according to the lower-risk schedule.10 A third patent included claims essentially directed to the second step described above, in particular, “reviewing the effects of known immunization schedules, as shown in the relevant literature.”11

In Classen, the Federal Circuit concluded that the claims in the third patent were invalid for failing to recite patent-eligible subject matter but that the claims in the other two patents covered patent-eligible subject matter.12 In reaching that conclusion, the Federal Circuit relied heavily on the immunizing-a-patient step in the acceptable claims because that step provided a practical application of the underlying concept.13

Conclusions

In view of the Mayo, Akamai, and Classen decisions, claim drafters will likely prepare more claims covering both diagnosis and treatment, and pharmaceutical companies will likely face more assertions of induced infringement for those claims. Consider a two-step method claim that recites (1) testing a patient for disorder X and (2) treating the patient with drug Y if the patient has disorder X. Like the immunizing-a-patient step in Classen, the treating-the-patient step in this claim should push it over the patent eligibility bar. That said, the claim would still need to satisfy other conditions for patentability, such as novelty and nonobviousness, to issue in a patent.

As for infringement of this two-step method claim, a laboratory would presumably perform the testing step, while a doctor or nurse-practitioner would presumably perform the treating step. If a pharmaceutical company’s labeling for drug Y caused, urged, encouraged, or aided those two steps, a patentee would contend that the pharmaceutical company induced infringement of this two-step method claim.14

In summary, for method claims concerning personalized medicine and diagnostics-related technologies, a treating-the-patient step should provide a practical application of the underlying concept and therefore impart patent eligibility to the method claim. Broad diagnosis-and-treatment claims in the biotech field should clear the patent eligibility bar more readily than broad method claims in other fields.15

Steven M. Amundson is a partner in the New York office of Frommer Lawrence & Haug LLP and head of the firm’s appellate practice group. The views expressed in this article do not necessarily reflect those of the firm or its clients.

If you have any questions about your subscription, click
hereto email us or call at (914) 740-2189.

You may also be interested in subscribing to the GEN magazine, an indispensable
resource for everyone involved in the business of translating discoveries at the
bench into solutions that fight disease and improve health, agriculture, and the
environment. Subscribe
today to see why over 60,000 biotech professionals read GEN to
keep current in the areas of genomics, proteomics, drug discovery, biomarker discovery,
bioprocessing, molecular diagnostics, collaborations, biotech business trends, and
more.